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Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
The Brazilian Controlled Drugs and Substances Act (Portuguese: Regulamento Técnico sobre substâncias e medicamentos sujeitos a controle especial), officially Portaria nº 344/1998, [1] is Brazil's federal drug control statute, issued by the Ministry of Health through its National Health Surveillance Agency (Anvisa).
The Brazilian Health Regulatory Agency (Portuguese: Agência Nacional de Vigilância Sanitária, Anvisa, literally National Health Surveillance Agency) is a regulatory body of the Brazilian government, created in 1999 during President Fernando Henrique Cardoso's term of office.
There are seven classification rules that are given in Annex VIII. MDCG guidance 2020-16 provides clarification of the classification rules and gives classification examples. [1] Only devices in the lowest risk class, class A, are excluded from the requirement of notified body oversight.
Substance-based medical devices encompass a varied array of products that fall under the purview of Regulation (EU) 2017/745 (MDR). Based on their intended purpose, they are classified according to rule 21 ("Devices composed of substances that are introduced via a body orifice or applied to the skin") of Annex VIII of the MDR .
Medical Devices regulations cover all the topics related to the laws, standards or submissions process, with which compliance is required by manifold national and international bodies to commercialize a medical device
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry” [1] whose goal was the standardization of medical device regulation across the world.
Medical device cannot be classified as a class I device because the controls authorized are insufficient to provide reasonable assurance of the safety and effectiveness of the device. Medical device has sufficient information to establish a performance standard and it is necessary to establish a performance standard for the device.